Starting January 1, 2021, companies placing biocidal products or biocidal active substances on the UK market have to comply with the UK Biocidal Product Regulation (UK-BPR) regime.
The national UK regime reflects the current EU framework. Active substance approvals and new biocidal product authorisations are specific to the United Kingdom. The UK Health and Safety Executive (HSE) is the national authority on biocides.
The HSE will transfer all existing EU article 95 entries to its own UK Article 95 list. To remain on this list, companies need to submit supporting information to the HSE. This is the same information submitted to ECHA, for example, an active substance dossier or a letter of access to data held by HSE. To meet these requirements, companies are provided a two-year phase-in period.
A biocidal product authorisation valid in the United Kingdom, retains its validity after January 1, 2021 until its normal expiry date. However, the authorisation holder needs to be established in the UK within one year (by January 1, 2022).
If you have an application being processed by another country in the EU, EEA or Switzerland as part of an EU-wide authorisation process (for example, a mutual recognition or union authorisation application), you need to resubmit your application to HSE if you intend to seek a national authorisation in the United Kingdom.
SCC Regulatory Services in the UK
For the UK market, we can provide you the following regulatory services:
- Developing a regulatory strategy, including a testing strategy for the UK
- Data transfers to UK HSE for existing approvals and authorisations
- Data gap analysis
- Legal services related to Letter of Access (LoA) issues by
- Preparing and submitting active substance approvals and product authorisations under the national regime
- Follow-up and defence
Please do not hesitate to contact our experts if you have questions or want to learn how we can help you ensure the regulatory compliance of your biocidal actives and products on the UK market.